Liquid specimen container and attachable testing modules

ABSTRACT

A biological fluid collection container comprising a cup member, a lid assembly removably mounted to the cup member having a housing with a downwardly extending cylindrical skirt, a luer lock with a throughgoing bore extending from one side of the lid housing. A hollow tube extends from the other side of the lid housing adjacent the luer lock and is axially aligned with the throughgoing bore of the luer lock. The hollow tube is provided with a plurality of throughgoing holes leading into its lumen along its surface to provide for a sampling along various liquid level layers of the biological fluid specimen collected in the cup member so that when the biological fluid specimen is removed from the cup member a representative sampling is obtained.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to a container used for collecting urineor other biological liquid specimens and for testing modules which canbe removably attached to the container. After the biological liquid hasbeen collected, the lid for the container is replaced and the containersealed by the patient or medical person handling the collection. Thepresent collection container allows for secondary collection of theurine specimen from along different fluid levels of the urine in thecontainer without removing the lid, thereby allowing a specimen to betested without contamination of the specimen from workers or materialsoutside the container. This transferring can be done without pouring orpipetting the collecting specimen. It can thus be seen that the presentinvention is directed to a medical and laboratory biological specimencollecting and testing apparatus. The urine container together withattachable testing modules is used in diagnostic cytology in the area ofclinical pathology in which diagnoses are made based upon a microscopicexamination of cell and other biological samples taken from a body site.The accuracy of the diagnosis depends both upon adequate patientsampling and culture or slide preparation procedures that result inoptimally interpretable specimens.

It is known that prompt processing of urine traditionally has beenrecommended to ensure accuracy of quantitative culture results,urinalysis and microscopy. This is important in making slides, in thatfresh cells stick to the glass slide much better than cells frompreserved urine, allowing a smoother cell spread onto the glass body.However, delays in processing and care of both inpatient and outpatientsettings and refrigeration is often neglected. One solution to the delayproblem is the use of chemical preservation of the urine and thispreservation system has been used in the field. The presence of liquidpreservative in the urine specimen raises the specific gravity of thespecimen to unmeasurable levels and limits the potential usefulness ofthe urine for various types of traditional quantitative analysis, suchas slide microscopy.

A number of urine or other biological liquid specimen containers havebeen developed allowing liquid biological specimens to be tested withoutremoving the lid of the urine or biological fluid container.

U.S. Pat. No. 2,953,132 discloses a parenteral solution bottle with aninwardly projecting tube and a rubber stopper and an associateddispenser bottle which is adapted to introduce the medication into theparenteral solution bottle.

U.S. Pat. No. 3,066,671 discloses a disposable additive containerprovided with a cover formed with a shaft guiding sleeve. The shaftguiding sleeve receives an infusion holder and an additive container.

U.S. Pat. No. 3,608,550 discloses a transfer needle assembly fortransferring fluid from a fluid source to a fluid collection container.The needle assembly includes a first cannula mounted on a support meanswhich engages the collection container and is adapted to be connected atits forward end to the fluid source and at its rear end to thecollection container. A second cannula is mounted on the support meansand is adapted to be connected at its forward end to the fluid sourceand at its rear end to the atmosphere allowing fluid to be transferredfrom a fluid source to a collection container by atmospheric pressurewhen the volume within the collection container is sufficientlyincreased.

U.S. Pat. No. 3,904,482 discloses an apparatus and method for thecollection, cultivation and identification of microorganisms obtainedfrom body fluids. The apparatus includes an evacuated tube containing aculture medium, an inert gaseous atmosphere and a vent-cap assembly. Thetube containing the culture medium is fitted with a stopper forintroduction of body fluid by means of a cannula and, after growth ofthe organisms, transfer of the cultured medium is completed forsubculturing or identification procedures.

U.S. Pat. No. 4,024,857 discloses a micro device for collecting bloodfrom an individual or other blood source into a blood sampler cup. Thecup has a removable vented truncated cone shaped top with a capillarytube passing through a well formed in the top proximate to the insidewall of the cup to deliver blood directly from the blood source to thecup.

U.S. Pat. No. 4,116,066 discloses a device for the collection of aliquid, such as urine comprising an open ended urine collectioncontainer provided with a hollow cannula attached to its bottom. Thecannula is slotted near its base, and serves as the conduit throughwhich liquid may be transferred from the container to an evacuated tube.When the stopper of the evacuated tube is punctured by the cannula, thepressure difference causes liquid deposited in the container to be drawnthrough the slot into the hollow cannula and into the tube.

Another attempt to solve this problem is seen in U.S. Pat. No.4,300,404, in which a container is developed having a liquid containerwith a snap fit lid. The lid is provided with a cannula which extendsinto the lower end of the container and which projects through the lidat its upper end so as to be able to pierce the stopper of anair-evacuated tubular container. The container is also provided with adepressed bottom to assure the maximum collection of fluids and the lidis provided with a recess to accommodate the air-evacuated tube.

SUMMARY OF THE INVENTION

The present invention is directed to a liquid collection containerhaving a skirted lid which is adapted to be screwed over the containerand a hollow tube connected to the container lid and axially alignedwith the bore of an integrally formed luer lock. The tube extends downinto the container and is provided with an open end and a series ofperforations extending up the length of the tube and communicating withthe tube lumen so that different levels of urine or biological fluidmaintained in the container can be simultaneously withdrawn from thecontainer by the use of a standard syringe and if desired through aquantitative measuring container for cytology/microbiology applicationsor through a chromatographic capsule for antigen capture and diagnosis.

It is thus the object of the invention to collect urine or other fluidsfor use in testing and to protect the fluid from outside contaminationand to allow easy transport of the fluid.

In the accompanying drawings, there is shown an illustrative embodimentof the invention from which these and other of the objectives, novelfeatures and advantages will be readily apparent.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded cross-sectional schematic view of the inventivecollection container;

FIG. 2 is a cross-sectional exploded schematic view of a chromatographiccapsule for antigen capture being mounted to the luer lock of thecollection container of FIG. 1 and operated by a syringe;

FIG. 3 is a cross-sectional schematic view of the chromatographiccapsule for antigen capture connected to the collection container ofFIG. 1 with fluid being withdrawn from the container into the syringebarrel for antigen capture;

FIG. 4 is a schematic cross-sectional sequential view of the assemblyshown in FIG. 3 shown drawing fluid through the chromatographic capsuleinto the syringe;

FIG. 5 is a schematic cross-sectional sequential view of the assemblyshown in FIG. 4 in which fluid is pumped back into the collectioncontainer after antigen capture;

FIG. 6 is a schematic cross-sectional view of the chromatographiccapsule used with the urine collection container showing exploded endplugs which can be used to hold the antigen beads in the capsule;

FIG. 7 is an alternate embodiment of the collection container using afemale luer lock modification;

FIG. 8 is a schematic exploded cross sectional view of acytology/microbiology container being attached to the female luer lockembodiment of FIG. 7;

FIG. 9 is a schematic cross sectional sequential view of acytology/microbiology container attached to the female luer lockembodiment and a syringe;

FIG. 10 is a cross-sectional view of a removed male member from thecytology container being placed on the side for cytology examination;and

FIG. 11 is a cross-sectional view of a microbiology container withcollection container removed, eluting a bacteriological sample into amicrobiological culture tray.

DETAILED DESCRIPTION OF THE INVENTION

The preferred embodiment and best mode of the invention is shown in FIG.1 and assembled in FIG. 2 and relates to a urine collection cup 10 inwhich urine or other biological liquid specimens may be collected. Aftercollection, the patient or supervising medical personnel places a lid 14on the cup housing 16. The cup housing 16 is provided with an externalthreaded surface 12. The lid 14 has a housing 20 which is molded with adownwardly directed cylindrical extended skirt or flange 22 which isthreaded 24 on its inner surface 23 for threading onto the externalthreaded surface 12 of cup housing 16. The lid housing 20 defines a well26 in which is seated an intregally molded threaded luer lock 28. Theluer lock 28 is provided with a throughgoing bore 29 leading to a hollowtube 30 which is preferably integrally molded or separately secured tothe other side of the lid housing with its lumen 31 being axiallyaligned with the bore 29 of the luer lock. The tube 30 has a series ofperforations 32 extending along its length and an open end 34 whichallow different fluid layers to be simultaneously tested when the urineor biological fluid is withdrawn from the cup. If desired, as shown inFIG. 2, a filter 36 of large pore size can be mounted in the open end 34to provide for filtration of larger urinary sediments in the urine orbiological liquid 100.

An adapter bead container capsule 40 as seen in FIGS. 2 and 6 isselected to be mounted to the lid luer lock 28. The capsule housing 42defines a chamber 44 in which is mounted a filter 45 for antigen beadscapture. The housing 42 has hollow nipple end members which define aninlet bore 46 which is axially aligned with luer lock bore 29 of the lidand an outlet bore 48 which will be axially aligned with the luer lockbore of syringe 64. End plugs 43 as shown in FIG. 6 seal the capsule 40after fluid has been passed through the bead chamber to deposit antigenon the beads.

The beads container housing 42 with treatment filter 45 mounted thereinpreferably has a filter particle size of 5 microns but can range from1-5 microns or any size which is suitable to allow fluid flow withantigens to pass therethrough but also prevent the passage of beads 60.Each end 47 and 49 of the bead container capsule 40 is fitted with athreaded projection which is adapted to fit onto a luer lock 62 of a 30cc syringe 64, manufactured by Becton Dickinson & Co. It should be notedthat any pump type device could be used in place of the syringe as forexample an autovial spunglass filter manufactured by Genex Corporation.The syringe 64 has a barrel 66, piston 68 and piston head 69. While thebead capsule 40 can be used for any body fluid it is primarily designedfor use in collecting concentrated urine antigen samples for use intesting for the presence of various kinds of cancer in the body todetermine the presence and stage of the cancer.

As shown in FIGS. 2 through 5 the beads container capsule 40 isconstructed of polystyrene. The capsule housing 42 defines a urineentrance port 46 and exit port 48. The chamber 44 of the beads containercapsule 40 contains a filter 45 and a bed of beads 60 with immobilizedantibodies positioned on the syringe side of the filter.

The beads 60 are preferably visible (above 10 micron in diameter) sothat their flow into the syringe (see FIG. 4) and back to the capsule 40(see FIG. 5) can be visually observed to make sure of maximum beadcontact with the urine. Antibodies are immobilized (covalently bound) onthe beads 60 as is well known in the art and are designed to havebinding sites which have a high affinity for the epitopes of the cancerantigens carried in the urine.

It should be noted that the volume of beads 60 is important and thebeads should not be greater then the volume of the capsule chamber 44 sothat the syringe neck will not become jammed.

The principle of affinity chromatography requires that a successfulseparation of a biospecific ligand is available and that it can bechemically immobilized to a chromatographic bed material, the matrix.Numbers of methods well known in the art have been used to couple orimmobilize antibodies to a variety of activated resins. Examples ofimmobilization techniques which exhibit variable linkage are thoseformed by the reaction of the reactive groups on the support with amino,thiol, hydroxyl, and carboxyl groups on the protein ligand. Theselection of the ligand is influenced by two factors. First, the ligandshould exhibit specific and reversible binding affinity for thesubstance to be purified and secondly it should have chemicallymodifiable groups which allow it to be attached to the matrix withoutdestroying its binding activity. (Examples of such are Protein GSepharose manufactured by Pharmacia, Hydrazide AvidGel Ax manufacturedby BioProbe International, and Actigel-ALD manufactured by SterogeneBioseparation Inc.)

An advantage to the use of Actigel-ALD is that it does not cross linkproteins therefore allowing proteins to retain high bioactivity aftertheir immobilization. Actigel-ALO SUPER FLOW also available fromSterogene Bioseparation Inc. permits a linear flow rate of up to 3000cm/h which would fit nicely with the flow rates in the apparatus (approx10-100 cm/min).

The resin bead material 60 with matrix and primary ligand (in this caseimmobilized antibody) having had flow contact with the filtered urine inbuffered form from the addition of 10 ml of 200 mM Tris buffer pH 7.8manufactured by Pharmacia captures through antigen-antibody reactionwith or immune reaction the specific ligand component carried by theurine namely, the non complexed antigen. This buffering agent adjuststhe urine pH. The buffer solution can be added to the collectioncontainer 10 by directly adding it from the syringe 64 prior towithdrawing the urine into the syringe or simply adding it to thecollection container 10 from another container. When the specificantigen is present in the urine testing sample 100 the antigen reactswith the antibody to form antigen-antibody complexes. The complexedantigen-antibody carried by beads 60 remains in the housing chamber 44as is clearly shown in FIG. 5. If there is an absence of the antigen inthe specimen sample 100 the antibody will remain unoccupied.

Testing is presently done by using 0.2-0.5 ml aliquots of urine. Thepresent high affinity beads 60 can capture the antigen present in 100 mlor even more of the sample, depending on the frequency of filling andemptying the syringe 64. This will result in 500× fold increase in theamount of antigen being captured by the beads. Preferably the syringebarrel 66 is filled with urine (see FIG. 4) allowing the beads to movefreely into the barrel of the syringe for maximum fluid contact andmixing. The syringe is emptied and refilled a number of times formaximum concentration so that 1,000× antigen concentrations from thatpreviously obtainable can be obtained.

The capsule 40 is removed from luer lock 62 of syringe 64 and ports 46and 48 are closed with plugs 43 as shown in FIG. 6 to provide a capsulefilled with concentrated specimen sample that can be shipped.Furthermore the specimen life of the buffered specimen is 6 months orlonger under ordinary storage conditions after washing the beads withpreservative solution e.g. 0.01% Sodium Agide (Bacteriostatic agents).

Upon receipt of the specimens the container is placed on a syringecontaining an eluting buffer which release the antigens from theantibody on the beads providing a concentrated antigen sample fortesting purposes.

A cytology/microbiology container 70 is also provided for alternate usewith the collection container. Both the cytology container 10 andantigen beads container capsule 40 are each adapted to be removablymounted to a syringe 64 which is of standard construction.

The cytology/microbiology container 70 as more clearly shown in FIGS.8-11 is alternately mounted to syringe luer lock 62 and the female luerlock 27 of collection cup 110 shown in FIG. 7. Eachcytology/microbiology container is easily opened and is constructed witha simple two-piece construction comprising a male filter membranecarrying member 74 and a female connector member 76 screwed onto themale member. The male filter membrane member 74 is provided with anouter cylindrical wall 85 having a threaded external surface 71, a base86 which extends past the cylindrical wall 85 to form a lip 87, and amale nipple 88 which extends outward from the base in an oppositedirection from wall 85. The nipple 88 is provided with an end flangewhich is adapted to be threaded into the threaded luer lock 62 of thesyringe 64 and defines a throughgoing bore 89 which leads into chamber80 defined by an inner inclined wall 72 of the male member. The innerwall 72 has a cylindrical exterior surface 79 and is spaced from theinner surface of outer wall 85 to define a channel 77. An annular stepor membrane seat 73 is cut into the inner surface of wall 72 to holdfilter membrane 84. An annular channel 75 is cut into the surface ofstepped end 78 of the inner wall 72 allowing the stepped end to fit overlocking prongs 94 extending from the female member thus holding the maleand female members in a sealed relationship while providing a safetystop for the filter membrane 84.

The female connector member 76 has an outer cylindrical housing 90 witha base 91. The housing is threaded on its inner surface 92 forengagement with the threaded external surface 71 of wall 85. The planarend wall 93 of housing 90 abuts against the outwardly extending flangeor lip 87 when the male and female members are screwed together. Thefemale connector base inner surface, which in combination with the innerwall surface of housing 90 defines the interior configuration of thefemale member, is concentrically stepped so that the outer step 96 abutsagainst the end of walls 85 and 72 and an inner step 98 abuts againstfilter membrane 84 and the distal stepped portion 79 of stepped end 78.The base 91 is provided with a threaded luer lock 99 on its exteriorsurface and defines a throughgoing bore 97 with a frustro conicalproximal end which leads to membrane 84 and chamber 80. As previouslynoted, nipple 88 of the cytology/microbiology container is fitted with athreaded projection which is adapted to fit onto the luer lock 62 of a30 cc syringe 64, manufactured by Becton Dickinson & Co. It should benoted that any pump type device could be used in place of the syringe 64as for example an autovial spunglass filter manufactured by GenexCorporation. The syringe 64 has a barrel 66 with associated luer lock62, piston 68 and piston head 69. While the cytology/microbiologycontainer 70 can be used for any body fluid it is primarily designed foruse with concentrated dialysis fluid and urine and for collectingassociated sediments and/or bacteria for use in testing for variouskinds of disease.

The male member 74 of the cytology/microbiology container 70 can containa nitrocellulose membrane filter 84a with a filter size of 13 mmdiameter and a porosity of approximately 0.45 microns for bacteriaentrapment as shown in FIG. 11 or in the case of cell cytology, apolycarbonate filter 84, as shown in FIG. 10. The polycarbonate filter84 has a five-micron pore size to trap the polymorphnuclear leukocytesor even lymphocytes which are seven and one half microns in size.

It should be noted that various composition filters can be used andinterchanged. One membrane filter that can be used for fluid screeningis LEUCOSORB, a leucocyte retention medium manufactured by PallBioSupport Division of Pall Corporation. Other membranes manufacturedand sold by the Pall Corporation are BIODYNE A, an unmodified nylon withsurface chemistry 50% amine and 50% carboxyl group with an isoelectricpoint of pH 6.5; BIODYNE B, a surface-modified nylon with surfacechemistry characterized by a high density of strong cationic quarternarygroups (the zeta potential is positive to pH>10); BIODYNE C, asurface-modified nylon with surface chemistry characterized by a highdensity of anionic carboxyl groups (the zeta potential is negative topH>3; an LOPRODYNE, a low protein binding nylon 66 membrane with atightly controlled microporous structure with high voids volume forrapid, efficient throughput of liquids and absolute retention ofmicroparticles designed for cell separation and bacterial cellimmunoassays. Fifty milliliters of dialysate will be pulled fromcontainer 10 through the desired filter membrane 84 or 84a dependingupon the analysis into syringe 64. After the requisite amount ofdialysate has been passed through the filter membrane, thecytology/microbiology container 70 and associated filter membrane isremoved. The polycarbonate membrane 84 is placed on a glass slide 120 asshown in FIG. 10 and stained with a modified Wrights stain for cytologicdetermination.

Thus, the method of transferring cells to a slide is that of membranefiltration (filtration of fluid specimens through membrane filters toincrease cell recovery). This particular technique provides the criticalfeature that the cells are evenly deposited over the slide with minimaloverlap as this will allow clear observation and optimal diagnosticaccuracy.

It should be noted that the process of transferring or collecting cellsonto a slide or membrane is largely affected by preserving or fixing thecytology specimen in the body fluid, secretions or smears.

Currently, body fluid samples are collected for cytological examinationsusing special containers. These containers usually contain apreservative solution for preserving the cytology specimen duringshipment from the collection site to the cytology laboratory.Furthermore, cytology specimens collected from the body cavities using aswab, smear, flush or brush are also preserved in special containerswith fixatives prior to transferring cells onto the slide or membranefor staining or examination.

It has been found by the present inventor that the recovery (yield) aswell as the quality of the cytology preparations from fresh body fluidspecimens is superior when compared to routine cytology preparationsthat were prepared when the same samples were preserved. This isprobably due to the fact that fresh cells stick better to glass and/ormembranes than those preserved in alcohol or other preservatives.

The inventive apparatus also allows for isolation and collection offresh cells and/or microorganisms from the body fluids to perform DNAprobing and chromosomal analysis once the cells are hemolysed by theproper buffer.

The most widely used stain for visualization of cellular changes incytology is the Papanicolaou staining procedure. This stain, which isused for both gynecologic and non-gynecologic applications, is basicallycomposed of blue nuclear and orange, red and green cytoplasmiccounterstains. The nuclear stain demonstrates the chromatin patternsassociated with normal and abnormal cells, while the cytoplasmic stainshelp to indicate cell origin. The success of this procedure can beattributed to the ability to observe a number of factors, includingdefinition of nuclear detail and cell differentiation. This stainingprocedure also results in a multicolor preparation that is very pleasingto the eye, possibly reducing eye strain.

Since cellular detail is dependent on fixation, it is extremelyimportant that cells be fixed immediately after being deposited on theslide. Too long a delay between preparation and fixation exposes thecells to air drying, which is detrimental to the cellular structure.Moreover, air drying artifact can adversely affect the subsequentstaining results. (An exception is when the cells are stained withWright-Giemsa, where air drying is used as the fixation step.)

New methodologies such as immunocytochemistry and image analysis requirepreparations that are reproducible, fast, biohazard-free andinexpensive. Different cell preparation techniques of the presentinvention address the issues of non-uniform cell densities, uneven celldistribution and air drying artifact. These preparations have resultedin an even distribution of cells that have superior morphology, whichhas improved light microscopic visualization and has allowed for the useof image cytometry instruments.

The effectiveness of transferring the cells from the filter to the slidehas proved to be very high without differential cell loss. (Microscopicexamination showed that the cell distribution was the same on the slideas on the filter.)

This procedure has many advantages for conventional cytology. The cellsare in a predetermined area allowing for significant timesaving whenscreening the slide. Such problems as cells lying outside the coverslipor on the frosted end are eliminated. Because cells are lying in asingle layer, they are almost always in a one focal plane when using a10× objective--the objective most often used for the lower powerscreening of a slide. Even with a 40× objective, most cells are infocus. This eliminates frequent refocusing and saves time.

The minimal cell overlap achieved in this process ensures that all cellsand cell groups can easily be examined with little chance for diagnosticcells to be obscured by clumps of overlapping cells or debris. Moreover,because the process takes place in the cytology laboratory, slidepreparation and fixation are controlled by laboratory personnel andquality assurance is easily implemented.

Multiple specimens can be made from a single patient sample. Additionalslides for other stain applications can be easily prepared. Humanpapilloma virus testing, for example, by newer methods such asimmunocytochemistry or in-situ hybridization can be performed on theadditional slides. As oncogene products or other immunocytochemicaltests are developed, more slides may be necessary. The differentfixations that these tests may need can easily be incorporated into theprocedure since the preparation does not require the slides to be fixedin only one way.

This same slide preparation procedure can be used for virtually allforms of cytology. Furthermore, the use of completely containeddisposable components addresses biohazard concerns. Ultimately, theenhanced presentation of cells, yielding improved cytologicinterpretation, may expand the role of cytology by providing moreconsistent and reliable patient diagnosis.

In bacteria testing the filter 84a while shown in FIG. 11 to be elutedand cultured in a standard petri dish 130 is preferably used forculturing with a Qualture device not shown but readily obtainable todetermine the presence of specific bacteria colonies. The Qualturedevice is a plastic capsule containing a filter membrane and fournutrient pads of dehydrated, selective media.

The Qualture technique is more sensitive than the agar plate method andmore rapid in determining a presumptive diagnosis. The device screens,isolates and presumptively diagnoses bacterial isolates in one step mostoften in 4-6 hours. Tests have demonstrated that recovery from fiftymilliliters of fluid is excellent and sensitive.

Thus it can be seen that the collection cup 10, syringe 64, antigencapture capsule 40 and cytology/microbiology container can be providedin kit form for easy use by the testing person in the desired mix andmatch combination.

In the foregoing description, the invention has been described withreference to a particular preferred embodiment, although it is to beunderstood that specific details shown are merely illustrative, and theinvention may be carried out in other ways without departing from thetrue spirit and scope of the following claims:

What is claimed is:
 1. A biological fluid collection containercomprising a cup member, a lid assembly removably mounted to said cupmember to form a fluid chamber, said lid assembly comprising a housingwith a downwardly extending cylindrical skirt which engages said cupmember, locking means extending from one side of said lid housingoutside said fluid chamber, said locking means defining a throughgoingbore, a hollow tube extending from an opposite side of said lid housingadjacent said locking means inside said cup member, said tube lumenbeing axially aligned with the throughgoing bore of said locking means,said hollow tube being provided with a plurality of throughgoing holesleading into its lumen along the length of its surface to provide for asimultaneous sampling along various liquid level layers of thebiological fluid specimen collected in the cup member.
 2. A collectioncontainer as claimed in claim 1 wherein said cup member is threaded onits upper outside surface and is adapted to be threaded to thread meansformed on the inside surface of said cylindrical skirt.
 3. A collectioncontainer as claimed in claim 1 wherein said hollow tube is open ended.4. A collection container as claimed in claim 1 wherein said hollow tubehas filter means mounted therein which screens large particulate matterfrom the fluid passing through the tube.
 5. A collection container asclaimed in claim 1 wherein said locking means is a luer lock.
 6. Acollection container as claimed in claim 1 wherein said locking means isa nipple member.
 7. A collection container as claimed in claim 1 whereinsaid lid housing defines a well in which said locking means is mounted.8. A biological fluid collection container comprising a cup member, alid assembly removably mounted to said cup member, said lid assemblycomprising a housing with a downwardly extending cylindrical skirt anddefining a central well, luer lock means mounted in said well andextending upward from said well outside of said cup member, said luerlock means defining a throughgoing bore, a hollow tube axially alignedwith the throughgoing bore of said luer lock extending into said cupmember, said hollow tube being provided with a plurality of throughgoingholes leading into its lumen along its longitudinal surface to providefor a constant fluid sampling along various liquid level layers of thebiological fluid specimen collected in the cup member.
 9. A biologicalfluid collection container as claimed in claim 8 including filter meansmounted in said hollow tube.
 10. An assembly for collecting molecularspecimens from a biological fluid sample comprising a cup member, a lidassembly removably mounted to said cup member to form a cup memberinterior, said lid assembly comprising a housing with connector meansadapted to receive and connect a specimen collection unit, luer lockmeans extending outside said cup member interior from one side of saidlid housing, said luer lock means defining a throughgoing bore, a hollowtube extending inside said cup member interior from the other side ofsaid lid housing adjacent said luer lock and axially aligned with thethroughgoing bore of said luer lock, said hollow tube being providedwith a plurality of throughgoing holes leading into its lumen along itssurface to provide for a sampling along various liquid level layers ofthe biological fluid specimen collected in the cup member, said specimencollection unit being removably mounted to said luer lock means of saidcup member lid, said specimen collection unit comprising a housingdefining at least one chamber, bead means with covalently bound antibodymeans positioned in one of said at least one chambers for the capture ofspecified antigen carried in the biological fluid sample; and a filtermeans housed in said specimen collection unit chamber to prevent flow ofbead means with covalently bonded antibody means carried by biologicalfluid sample into said cup member while allowing flow of said bead meansinto a pump means removably mounted to said specimen collection unithousing.
 11. An assembly as claimed in claim 10 including a pump meansmounted to said specimen collection unit housing.
 12. An assembly asclaimed in claim 11 wherein said pump means is a syringe.
 13. A testingapparatus for collecting cytology or bacterial specimens from abiological fluid comprising a pump means, a specimen collection housingdefining a chamber with an inlet and outlet means adapted to beremovably mounted to said pump means, said specimen collection housingoutlet means communicating with said pump means, a filter means mountedto said housing in said chamber which allows said biological fluid toflow therethrough and a cup member removably mounted to said specimencollection housing, a lid means removably mounted to said cup memberforming a fluid chamber, said lid means comprising a housing defining awell with hollow luer lock means positioned in the well of said lidhousing and extending outside of said fluid chamber, said luer lockmeans defining a throughgoing bore which communicates with an aperturedefined in said lid housing, a hollow tube axially aligned with thethroughgoing bore of said luer lock extending away from said luer lockmeans into said fluid chamber, said hollow tube being provided with aplurality of throughgoing holes leading into its lumen along its surfaceto provide for a sampling along the length of various liquid levellayers of the biological fluid specimen collected in the cup member. 14.A testing apparatus as claimed in claim 13 wherein said filter means hasa pore size of 0.45 microns.
 15. A testing apparatus as claimed in claim13 wherein said filter means has a pore size of 5 microns.